Gut bacteria drug shows promise against blood disorder
NCT ID NCT03820817
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested whether the oral antibiotic rifaximin can reduce abnormal proteins in people with monoclonal gammopathy, a condition that can lead to blood cancers. Fifty adults with different types of gammopathy took the drug to see if it lowered their immunoglobulin levels by at least 25%. The goal was to find a new way to control the disease by targeting bacteria in the gut.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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May 2019
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria * Patients will be enrolled into one of 3 cohorts: * Cohort A: IgA gammopathy * Cohort B: IgG gammopathy / or light chain gammopathy * Cohort C: IgM gammopathy / asymptomatic macroglobulinemia * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have received antibiotics within last 3 weeks * Patients who are receiving any other investigational agents for gammopathy. Patients with clinical myeloma requiring anti-myeloma therapy are also excluded * History of allergic reactions or intolerance attributed to rifaximin or compounds of similar chemical or biologic composition to antibiotic under study * The effects of rifaximin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of rifaximin administration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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